Amar Ice by AMAR REMEDIES LIMITED AMAR ICE- menthol gel

Amar Ice by

Drug Labeling and Warnings

Amar Ice by is a Otc medication manufactured, distributed, or labeled by AMAR REMEDIES LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Menthol 2.5%

Purpose

Topical analgesic

Uses

• temporarily relieves minor aches and pains of muscles and joints associated with:
  • arthritis
  • bruises
  • simple backache
  • sport injuries
  • strains
  • sprains
• provides cooling penetrating relief

Warnings

For external use only

Do not use

• with heating pads or heating devices

When using this product

• do not use in or near the eyes
• do not apply to wounds or damaged skin
• do not bandage tightly

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
• redness or irritation develops

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean affected area before applying product
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Other information

• store in a cool place
• keep lid tightly closed
• do not use, pour, spill or store near heat or open flame

Inactive ingredients

Water, Camphor, Carbopol, Methyl Paraben Sodium, Propyl Paraben Sodium, Wintergreen oil, Propylene Glycol, Phenoxy ethanol, ISO Propyl alcohol, Sodium Hydroxide, Cl 42090.

PRINCIPAL DISPLAY PANEL - 227 g Jar Label

Amar

ICE GEL

Net Wt 8 oz (227g)

INGREDIENTS AND APPEARANCE

AMAR ICE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41499-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Camphor (Synthetic) (UNII: 5TJD82A1ET)	0.7 g  in 100 g
MethylParaben Sodium (UNII: CR6K9C2NHK)
PropylParaben Sodium (UNII: 625NNB0G9N)
Methyl Salicylate (UNII: LAV5U5022Y)
Propylene Glycol (UNII: 6DC9Q167V3)
Phenoxyethanol (UNII: HIE492ZZ3T)
Propyl Alcohol (UNII: 96F264O9SV)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41499-123-01	227 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/01/2010

Labeler - AMAR REMEDIES LIMITED (677141751)